Osteo Acl Screw MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,
FDA 510(k) K032894 · Linvatec Biomaterials, Inc.
510(k) numberK032894
Submission
- Device name
- Osteo Acl Screw MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,
- Applicant
- Linvatec Biomaterials, Inc.
Tampere, FI - Received
- September 17, 2003
- Decision date
- May 7, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K052080 | Matryx Interference ScrewHWC · Special | 08/25/2005SE |
| K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…MAI · Special | 11/19/2004SE |
| K042517 | Biosorb FX and Biosorb PDX 1.5 and 2.0 ScrewsJEY · Special | 10/08/2004SE |
| K042295 | Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020HWC · Special | 09/16/2004SE |
| K041288 | Modification to SmartpinHTY · Special | 06/10/2004SE |
| K032447 | Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially ThreadedHWC · Special | 04/16/2004SE |
| K031981 | 2.4 Smartnail, Models 532416, 532425, 532435, 532445MAI · Special | 07/25/2003SE |
Questions and answers
When was Osteo Acl Screw MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, cleared by the FDA?
Osteo Acl Screw MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, (K032894) received a 510(k) decision of Substantially Equivalent on May 7, 2004, 233 days after the submission was received.
What is the product code of K032894?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.